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1,688 stories matching this filter · ← front page

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  • Roche signs discovery partnerships with Atavistik Bio and Earendil Labs
    Roche announced new collaborations with the drug discovery companies Atavistik Bio and Earendil Labs to develop early-stage candidates. The agreements continue a recent wave of dealmaking by the S…
    Endpoints · 1mo agoDealNeutral↗ source
  • Acadia’s Alzheimer’s psychosis drug misses Phase 2 goals, but moves to revised Phase 3
    Acadia Pharmaceuticals announced that its experimental treatment for psychosis linked to Alzheimer’s disease failed to meet the primary endpoints in a Phase 2 trial. The company said the data stil…
    Endpoints · 1mo agoNegative readoutNegative↗ source
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Pain780
Nephrology764
  • Merck's $1.3B EyeBio investment yields first ophthalmology success
    Merck's strategic move to re-enter ophthalmology has begun to show results after its 2024 acquisition of EyeBio. The company committed $1.3 billion upfront for EyeBio, aiming to broaden its pipeli…
    Endpoints · 1mo agoDealPositive↗ source
  • Kyverna reports positive one-year CAR-T results for rare stiff person syndrome, supporting FDA filing
    Kyverna Therapeutics announced that its CAR-T therapy for stiff person syndrome showed positive results after one year of treatment. The trial involved patients with the rare autoimmune disorder,…
    Endpoints · 1mo agoPositive readoutPositive↗ source
  • Abiomed issues recall of Automated Impella Controllers over purge cassette detection issue
    Abiomed has announced a recall of its Automated Impella Controllers after identifying failures in the purge cassette recognition system, which could lead to prolonged delays in mechanical circulato…
    fda medwatch · 1mo agoRegulatoryNegative↗ source
  • Elevar Therapeutics receives FDA approval for Lyrfigtu as second-line treatment for bile duct cancer
    The U.S. Food and Drug Administration has approved Elevar Therapeutics' drug Lyrfigtu as a second‑line option for patients with bile duct cancer who meet specific criteria. Bile duct cancer is dia…
    Endpoints · 1mo agoApprovalPositive↗ source
  • AI doomsday warnings may curb health-tech innovation, Epic cautions
    Recent commentary warns that sensational AI doomsday predictions could slow the pace of health‑technology innovation. Epic, the large electronic health‑record company that provides AI tools to hos…
    Endpoints · 1mo agoNegative↗ source
  • Sarepta Therapeutics agrees to pay $39 million to settle gene therapy dispute with Regenxbio
    Sarepta Therapeutics has agreed to resolve a dispute with Regenxbio by paying $39 million. The payment settles claims related to gene therapy technology that both companies have been developing.…
    Endpoints · 1mo agoDealNeutral↗ source
  • Heidi Overton, Trump’s FDA commissioner nominee, to face Senate confirmation hearing
    Heidi Overton has been nominated by President Donald Trump to serve as the next commissioner of the U.S. Food and Drug Administration. She is scheduled to appear before the Senate Health, Educatio…
    Endpoints · 1mo agoRegulatoryNeutral↗ source
  • Galil Importing Corp recalls Lior ground cinnamon over elevated lead levels
    Galil Importing Corp of Hauppauge, New York announced a recall of its Lior Cinnamon Ground Seasoning because of potential elevated lead contamination. The product, distributed to retail outlets in…
    fda recalls · 1mo agoRegulatoryNegative↗ source
  • Deano’s Pasta recalls 20 lbs of ravioli over undeclared lobster allergen
    Deano’s Pasta of Somerville, Massachusetts announced a recall of its Pear and Pecorino Triangoli Ravioli after discovering the product may contain undeclared lobster, a crustacean shellfish allerge…
    fda recalls · 1mo agoRegulatoryNegative↗ source
  • FDA approves Eli Lilly's once-weekly insulin pen, setting up rivalry with Novo
    Eli Lilly’s once-weekly basal insulin shot Onswik has been approved by the FDA for patients with type 2 diabetes. Lilly has touted Onswik as a longer-acting alternative to daily basal insulin injec…
    Endpoints · 1mo ago↗ source
  • Convenience Kit Correction: Becton Dickinson Issues Correction for Kits and Procedure Trays Containing Recalled Sodium Chloride Ampules
    BD is correcting convenience kits and procedural trays containing recalled Huons Co. sodium chloride ampules
    fda medwatch · 1mo ago↗ source
  • FDA panel questions effectiveness of Grail's early-cancer detection test
    FDA's Molecular and Clinical Genetics Panel and agency officials raised concerns about Grail's next-generation sequencing test designed to detect multiple cancers early in adults over 50. The advi…
    Endpoints · 1mo agoRegulatoryNegative↗ source
  • World's first personalized gene-editing therapy costs $1.65 million per patient, project director says
    At a rare disease conference in Oxford, Fyodor Urnov disclosed that the world's first therapy designed to correct an individual’s unique genetic mutation cost $1.65 million to produce. The treatme…
    Endpoints · 1mo agoNeutral↗ source
  • FDA issues early alert on React Health VOCSN ventilators over connector fault
    The FDA's Center for Devices and Radiological Health has posted an early alert about a potential high‑risk problem with certain VOCSN ventilator units made by Ventec Life Systems, operating as Reac…
    fda medwatch · 1mo agoRegulatoryNeutral↗ source
  • Former Changsheng biotech chair sentenced to life in prison over Chinese rabies vaccine scandal
    Chinese authorities sentenced Gao Junfang, the former chairwoman of Changsheng Biotechnology, to life imprisonment after a court found her guilty of wrongdoing in a rabies vaccine scandal. The cas…
    Endpoints · 1mo agoRegulatoryNegative↗ source
  • Enveda secures $311 million in third consecutive megaround to advance discovery and weight-maintenance programs
    Enveda, a biotech startup operating out of Colorado and India, announced a new financing round on September 23, 2026. The company raised $311 million, marking its third large-scale funding round i…
    Endpoints · 1mo agoDealPositive↗ source
  • AI startup Basecamp Research secures $140 million Series C funding and outlines six-program AI pipeline
    Basecamp Research, an AI-driven biotech founded in 2019, announced a $140 million Series C financing round. The company said the new capital will support its ambitious six-program pipeline that ap…
    Endpoints · 1mo agoDealPositive↗ source
  • Roche reports positive interim Phase 3 results for kidney drug, paving way for accelerated approval
    Roche announced interim results from its Phase 3 trial of a kidney disease therapy, indicating the study met its primary endpoints. The data, released on Wednesday, suggest the drug could qualify…
    Endpoints · 1mo agoPositive readoutPositive↗ source
  • FDA issues early alert on Abiomed Impella controller safety issue
    The FDA Center for Devices and Radiological Health (CDRH) has posted an Early Alert about a potential high risk problem with certain Abiomed Impella automated controllers. Abiomed has sent a lette…
    fda medwatch · 1mo agoRegulatoryNegative↗ source
  • Roivant's FcRn drug IMVT-1402 fails Phase 2b lupus trial
    Roivant announced that its FcRn-targeting antibody IMVT-1402 (imeroprubart) failed to meet primary endpoints in a Phase 2b trial in patients with lupus. The study did not show improvement in disea…
    Endpoints · 1mo agoNegative readoutNegative↗ source
  • Family’s struggle to receive cystic fibrosis medication highlights care gaps
    Stephanie Marquart in Knoxville, Tennessee, waited anxiously for a delivery to her home, refreshing the tracking page repeatedly as the package made its way to her doorstep. The episode, described…
    Endpoints · 1mo agoNegative↗ source
  • Federal Court Issues Consent Decree Halting Gold Star Distribution's FDA-Regulated Shipments Over Unsanitary Warehouse
    The U.S. District Court for the District of Minnesota entered a consent decree on Sept. 21, 2026 that permanently enjoins Gold Star Distribution, Inc. and its owner Bassam Abu Samrah from distribut…
    fda press · 1mo agoRegulatoryNegative↗ source
  • Berlin Seeds recalls 950 lbs of alfalfa sprouting seed over possible STEC and Salmonella contamination
    Berlin Seeds of Millersburg, Ohio announced a recall of 950 pounds of its alfalfa sprouting seed. The recall was triggered because the seed could be contaminated with Shiga toxin‑producing Escheri…
    fda recalls · 1mo agoRegulatoryNegative↗ source